BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (BrenDeLL-Lung01)

NCT07625644 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: BL-M14D1-LC-301
• Study Type: interventional
• Target: 550
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

Conditions

Small Cell Carcinoma; Sclc; Lung Cancer; Lung Cancer Stage IV; Small Cell Lung Cancer Extensive Stage; Small-cell Lung Cancer; Lung Cancer Metastatic; SCLC,Extensive Stage

Keywords

DLL3; First Line

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)

  Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression, as assessed by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause, whichever occurs first.

  Up to approximately 2 years

Secondary Outcomes (11)

• Overall Survival (OS)

  Up to approximately 2 years

• Participants with Serious Adverse Events (SAEs)

  Up to approximately 5 years

• Participants with treatment-emergent adverse events (TEAEs)

  Up to approximately 5 years

• Evaluate the safety of BL-M14D1 in combination with atezolizumab

  Up to approximately 5 years

• Participants with abnormal lab results

  Up to approximately 5 years

Study Arms (3)

Arm A

EXPERIMENTAL

BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days

Drug: BL-M14D1 and Atezolizumab

Arm B

EXPERIMENTAL

BL-M14D1: Administered on days 1 of every 21 days Atezolizumab: Administered dose on days 1 of every 21 days

Drug: BL-M14D1 and Atezolizumab

Arm C

ACTIVE COMPARATOR

Medications used in the Control Arm should be administered per local label or institutional guidelines. Induction therapy (4 cycles): Carboplatin (AUC of 5 mg/mL\*min IV) on Day 1 of each 21-day cycle Etoposide (100 mg/m2 IV) on Days 1 through 3 of each 21-day cycle Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Maintenance therapy (continues until discontinuation criteria are met): Atezolizumab (1200 mg) IV on Day 1 of each 21-day cycle Lurbinectedin (3.2 mg/m2) IV on Day 1 of each 21-day cycle (to be added only if approved in region and as per PI discretion)

Drug: Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin

Interventions

BL-M14D1 and Atezolizumab DRUG

BL-M14D1 administered in combination with atezolizumab. BL-M14D1 will be given intravenously at the protocol-specified dose and schedule. Atezolizumab will be administered intravenously according to the approved dosing regimen.

Also known as: BL-M14D1, Atezolizumab

Arm A; Arm B

Carboplatin+ Etoposide + Atezolizumab followed by Atezolizumab and Lurbinectedin DRUG

Carboplatin and etoposide will be administered intravenously in combination with atezolizumab for induction therapy, followed by maintenance treatment with atezolizumab with or without lurbinectedin per protocol.

Also known as: Etoposide, Atezolizumab, Lurbinectedin, Carboplatin

Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)
• Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.
• At least one measurable lesion based on RECIST v1.1 per investigator assessment.
• An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
• Adequate organ function

You may not qualify if:

• Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.
• Participants who have received prior topoisomerase inhibitor-based ADC therapy.
• Participants with history of severe heart disease
• Participants with active autoimmune diseases and inflammatory diseases,
• Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years

Sponsors & Collaborators

• SystImmune Inc.: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Small Cell; Lung Neoplasms

Interventions

atezolizumab; EC regimen; PM 01183; Etoposide; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes

Study Officials

• Rishi Jain, MD

  SystImmune Inc.

  STUDY DIRECTOR

Central Study Contacts

Beth Metzheiser

CONTACT

425-453-6841; beth.metzheiser@systimmune.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded Independent Central Review (BICR)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: July 16, 2026

Record last verified: 2026-07